SmPC - Raloxifene hydrochloride 60mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Raloxifene hydrochloride 60mg Film-coated Tablets)
Last updated on this site: 08 Feb 2023
Variation Description:
To update sections 4.4, 4.8 (ADR), 4.9, 5.1 and 5.3 of the SPC in line with reference product, Evista 60mg Film Coated Tablets. Consequently, the PIL has been updated.
Additionally, section 4.4 of the SPC and PIL have been updated to align with the latest EC Excipient guidance (version 10.2) for lactose and sodium.
SmPC section updated – 4.4, 4.8, 4.9, 5.1, 5.3 and 10.
Last updated on this site: 08 Feb 2023
Variation Description:
To update sections 4.4, 4.8 (ADR), 4.9, 5.1 and 5.3 of the SPC in line with reference product, Evista 60mg Film Coated Tablets. Consequently, the PIL has been updated.
Additionally, section 4.4 of the SPC and PIL have been updated to align with the latest EC Excipient guidance (version 10.2) for lactose and sodium.
SmPC section updated – 4.4, 4.8, 4.9, 5.1, 5.3 and 10.
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Changes: (Updated: 08 Feb 2023)
Variation Description:
To update sections 4.4, 4.8 (ADR), 4.9, 5.1 and 5.3 of the SPC in line with reference product, Evista 60mg Film Coated Tablets. Consequently, the PIL has been updated.
Additionally, section 4.4 of the SPC and PIL have been updated to align with the latest EC Excipient guidance (version 10.2) for lactose and sodium.
SmPC section updated – 4.4, 4.8, 4.9, 5.1, 5.3 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload